(23 days)
The MaxTorque™ Screw System is intended to stabilize and aid in the repair of fractures, fusions, and osteotomies for small bones and bone fragments.
The MaxTorque™ Screw System is indicated for use in long and small bone fracture, fusion, and osteotomy fixation, which includes but is not limited to the following:
- Fractures of the tarsal and metatarsals
- Fractures of the olecranon, distal humerus
- Fractures of the radius and ulna
- Patellar fractures
- Distal tibia and pilon fractures
- Fractures of the fibula, medial malleolus, os calcis
- Tarso-metatarsal and metatarsal-phalangeal Arthrodesis
- Metatarsal and Phalangeal osteotomies
- Osteochondritis dissecans
- Ligament fixation
- Other small fragment, cancellous bone fractures and osteotomies
The submission is a modification to the MaxTorque™ Screw System to add additional screw styles and lengths. No modifications were made to the existing implants. The MaxTorque™ Screw System consists of screws of various diameters, lengths and thread configurations. The system also includes correspondingly sized washers, the use of which is optional.
The furnished information pertains to a conventional medical device (MaxTorque™ Screw System), not an AI/ML-driven device. As such, the typical acceptance criteria and study designs associated with AI/ML device performance (e.g., accuracy, sensitivity, specificity, reader studies, ground truth establishment by experts) are not applicable here.
This submission is for a modification to an existing screw system, adding new screw styles and lengths. The substantial equivalence is based on similarities in indications, design, and materials to previously cleared devices, supported by calculations and finite element analysis comparing the strength of the new and predicate devices.
Therefore, the specific information requested in the prompt, which is tailored for AI/ML-based medical devices, cannot be extracted from this document. The document focuses on demonstrating physical and mechanical equivalence for a hardware modification, not an algorithmic performance.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.